Welcome!

Microsoft Cloud Authors: Pat Romanski, Lori MacVittie, Andreas Grabner, Jim Kaskade, John Basso

News Feed Item

Publication of two pivotal Phase III studies of regorafenib: Positive Phase III Data on Bayer's Regorafenib in Metastatic Colorectal Cancer (mCRC) and Gastrointestinal Stromal Tumor (GIST) Published in The Lancet

  • First publication of the global Phase III CORRECT and GRID study data of the oral multi-kinase inhibitor regorafenib

TORONTO, Nov. 27, 2012 /CNW/ - Bayer HealthCare today announced that the results of two pivotal Phase III studies for regorafenib were published online in the journal The Lancet ahead of a future print publication. Data from the CORRECT (Metastatic Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) and GRID (GIST - Regorafenib In Progressive Disease) trials provide robust evidence for the efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumor (GIST) who have exhausted all other treatment options.

"The publication of the CORRECT and GRID trials in The Lancet signifies the potential of regorafenib as a new and effective treatment option for both mCRC and GIST, where there is a high unmet need," said Dr. Shurjeel Choudhri, Vice President, Medical and Scientific Affairs. "Bayer is dedicated to developing innovative therapies to improve patient's lives and we will continue to expand our oncology portfolio to make a difference for patients and physicians."

CORRECT Trial

In the Phase III CORRECT trial regorafenib plus best supportive care (BSC) significantly improved overall survival (OS) (HR=0.77, 1-sided p-value=0.0052) and progression-free survival (PFS) (HR=0.49, 1-sided p-value <0.000001) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. In the study, median OS was 6.4 months with regorafenib versus 5.0 months with placebo; median PFS was 1.9 months with regorafenib versus 1.7 months with placebo. The data also showed a survival benefit in the regorafenib arm across nearly all subgroups analyzed, including no significant difference between patients with KRAS wild-type tumor and those with KRAS mutant tumor.  No difference in overall response rate was observed.

"Although there has been progress in the treatment of metastatic colorectal cancer, drug resistance remains a huge challenge," says Dr. Christine Cripps, Professor of Medicine University of Ottawa Cancer Centre.  "Regorafenib is a unique oral multi-kinase inhibitor that has the potential to become a new standard of care in mCRC and provides hope for those patients who until now would have had no further options."

The most common grade 3+ adverse events (≥5% of patients) were hand-foot skin reaction (16.6% vs. 0.4%), fatigue (15.0% vs. 8.3%), diarrhea (8.2% vs. 2.0%), hypertension (7.6% vs. 0.8%), and rash/desquamation (5.8% vs 0.4%). Quality of life was not adversely affected by regorafenib. The most serious adverse drug reactions in patients receiving regorafenib were severe liver injury, hemorrhage and gastrointestinal perforation.

GRID Trial

The Phase III GRID trial, also published in The Lancet, showed that regorafenib plus BSC significantly improved PFS compared to placebo plus BSC (HR=0.27, p<0.000001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib, which means a 73% reduction in the risk of progression or death. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm. In addition, there was a positive trend in the regorafenib group in improving OS (HR=0.772, p=0.199); however, the OS did not reach statistical significance which was expected due to the cross-over design of the trial that allowed patients receiving placebo to receive regorafenib following disease progression.

Furthermore, a significantly greater disease control rate (DCR) was observed with regorafenib plus BSC compared to placebo plus BSC (52.6% vs. 9.1%; p<0.000001), DCR was defined as rate of complete response [CR] plus partial response [PR] plus durable stable disease [SD] maintained for at least 12 weeks. In addition, regorafenib demonstrated therapeutic benefit independent of prior treatment options based on analysis in pre specified subgroups that showed regorafenib had a statistically significant PFS benefit over placebo for patients receiving regorafenib as a third- or fourth-line treatment.

The most common grade 3 regorafenib-related adverse events which had higher incidence (≥5% ) in the regorafenib plus BSC vs placebo plus BSC were hypertension (27.3% vs 4.5%), hand-foot skin reaction (20.5% vs 0%), and diarrhea (7.6% vs 0%%).  Grade 4 AEs were reported at a similar incidence in the regorafenib plus BSC vs placebo plus BSC (6.8% vs 6.1%).

About the CORRECT Trial

The Phase III study CORRECT randomized 760 patients with mCRC whose disease had progressed after currently approved standard therapies to receive regorafenib plus BSC or placebo plus BSC at a 2:1 ratio. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was OS. Secondary endpoints included PFS, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups were also compared.

About the GRID Trial

GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib. Patients were randomized in a 2:1 ratio to receive either regorafenib (160 mg once daily, 3 weeks on/1 week off) plus BSC or placebo plus BSC to evaluate efficacy and safety. The primary endpoint of this trial was PFS, and secondary endpoints included OS, time to progression, disease control rate, tumor response rate, duration of response, and safety of regorafenib.  Patients initially randomized to placebo were allowed to cross over to open-label regorafenib once the disease progressed, of which 85% of the patients from the placebo arm did cross over.

About Stivarga® (regorafenib)

Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases that are involved in mechanisms associated with tumor growth and progression (oncogenesis),  blood vessel development (angiogenesis), and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases (VEGFR1 and murine VEGFR2/3) that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including, KIT, RET, RAF-1, B-RAF, B-RAFV600E, PDGFR, and FGFR1, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.

Regorafenib has been submitted to Health Canada for marketing approval for the treatment of metastatic CRC and GIST. Market authorization in Canada has not yet been obtained.

Regorafenib was approved by the U.S. Food and Drug Administration for the treatment of mCRC and is marketed as STIVARGA® and has received priority review for treatment in GIST.  Bayer has also submitted for marketing approval of regorafenib for the treatment of metastatic CRC in the EU in May 2012. The NDA for regorafenib for the treatment of advanced CRC filed in Japan in July 2012 was granted priority review.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology.

About Bayer Inc.

Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $808 million CDN in 2011. Globally, the Bayer Group had sales of over 36 billion Euro in 2011. Bayer Inc. invested approximately $13 million CDN in research and development in 2011. Worldwide, the Bayer Group spent the equivalent of over 2.9 billion Euro in 2011 in R&D. For more information, go to www.bayer.ca.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


SOURCE Bayer Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
"Dice has been around for the last 20 years. We have been helping tech professionals find new jobs and career opportunities," explained Manish Dixit, VP of Product and Engineering at Dice, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2017 New York The 7th Internet of @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, New York. Chris Matthieu is the co-founder and CTO of Octoblu, a revolutionary real-time IoT platform recently acquired by Citrix. Octoblu connects things, systems, people and clouds to a global mesh network allowing users to automate and control design flo...
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Businesses and business units of all sizes can benefit from cloud computing, but many don't want the cost, performance and security concerns of public cloud nor the complexity of building their own private clouds. Today, some cloud vendors are using artificial intelligence (AI) to simplify cloud deployment and management. In his session at 20th Cloud Expo, Ajay Gulati, Co-founder and CEO of ZeroStack, will discuss how AI can simplify cloud operations. He will cover the following topics: why clou...
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...